Identification of Biomarkers in Cervical Mucus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cervical mucus sampling.
- Who it may be relevant to
- Registry conditions: Cervical Mucus Dysfunction, Infertility, Female. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Identification of Diagnostic, Prognostic and Predictive Biomarkers in Cervical Mucus for Reproductive and Gynecological Disorders
Overview
Cervical mucus is a biological fluid secreted by the endocervical glandular epithelium whose quantitative and qualitative characteristics vary in response to the hormonal stimulus produced by the ovary during the woman's menstrual cycle. As a fertility factor, it performs numerous biological functions: transport, nourishment, defense and capacitation of spermatozoa, defense against pathogens of the female genital tract. The aim of this research will be to deepen the knowledge of the biochemical characteristics of cervical mucus, in particular to perform characterization by infrared spectroscopy, for the identification of diagnostic, prognostic and predictive biomarkers for disorders affecting the female reproductive system. A healthy control population and a cohort of patients affected by unexplained infertility will be enrolled for the longitudinal study of the menstrual cycle with ultrasound and hormonal monitoring and serial sampling of cervical mucus.
Interventions
- Diagnostic test cervical mucus sampling
Monitoring of menstrual cycle will be conducted in the follicular, ovulatory and luteal phases during which cervical mucus, serum and urine samples will be collected and pelvic ultrasound scans performed (3-5 ultrasound scans/samples within the cycle).
Primary outcome measures
- Characterization by infrared spectroscopy of cervical mucus [Time frame: 1 month (3 time points within a menstrual cycle)]
Eligibility criteria
Inclusion criteria
- HEALTHY CONTROL
- Women of 18-45 years old,
- Use of the Billings Ovulation Method® for at least three months in the last three years
- Proven fertility
- STUDY COHORT
- Women of 18-45 years old,
- Women affected by unexplained infertility
Exclusion criteria
- Virgo women
- Women incapable of understanding and wanting
- Women who have had sexual intercourse in the two days prior to cervical mucus sampling
- Pregnancy, exclusive breastfeeding
- Amenorrhea
- Gynecological hormone ongoing therapies or suspended for less than three months
- Cervico -vaginal infections
- Psychiatric pathologies
- Untreated/decompensated endocrine-metabolic disorders
- Coagulopathies and renal pathologies under dialysis treatment
- Refusal of informed consent
- Previous, current or suspected oncological pathology
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetric — Rome
Identifiers
NCT: NCT06771401 · 7175